Senior Biostatistician

---

Job description

Senior Biostatistician

Cambridge, MA

Requisition Number: STS21-901

Blueprint Medicines is a global precision therapy company that invents life-changing therapies for people with cancer and hematologic disorders. Applying an approach that is both precise and agile, we create medicines that selectively target genetic drivers, with the goal of staying one step ahead across stages of disease. Since 2011, we have leveraged our research platform, including expertise in molecular targeting and world-class drug design capabilities, to rapidly and reproducibly translate science into a broad pipeline of precision therapies. Today, we are delivering approved medicines directly to patients in the United States and Europe, and we are globally advancing multiple programs for genomically defined cancers, systemic mastocytosis, and cancer immunotherapy.

What will you do?

This position is responsible for statistical aspects of study designs, planning and execution of statistical analyses for multiple clinical development programs, health authority submissions, presentations and publications, by working closely with colleagues in clinical development, translational medicine and research, and with key outsourced functions including data management, SAS programming, clinical pharmacology, medical writing, and regulatory affairs to advance Blueprint Medicine's drug candidates under development. This position will perform tasks under the guidance of the supervisor, and gradually gain independency.

What will be your responsibilities?

* Contribute to clinical protocol development, including authoring of the section on statistical methods and reviewing/editing of all sections.
* Author statistical analysis plans for clinical trials, and author/edit mock tables, listings and figures.
* Review CRF designs to ensure data collection meet the study objectives and the requirements of statistical analyses.
* Specify randomization schedules and test their implementations.
* Work with external statistical programmers and data managers to generate tables, listings and figures.
* QC the key results of statistical programmers.
* Support ongoing safety review of the program/study teams and data monitoring committees.
* Perform ad hoc statistical analyses and basic SAS programming as needed.
* Contribute to the clinical study reports, including authoring of statistical sections and interpretation of the study results.
* Support regulatory submissions.
* Support the preparation of publications, including manuscripts, posters and oral presentations.
* Provide requirements and oversight to external statistical programmers, data managers and other relevant functions at CROs to ensure quality of deliverables.
* Participate in department and cross-functional meetings to optimize clinical study designs, endpoints, and analysis strategies.
* Keep abreast of new developments in statistics, drug development and regulatory guidance through literature review, conference attendance, etc.

What qualifications do we require?

* PhD in statistics or a related field with 0 to 3 years of clinical trial experience in the pharmaceutical industry, or MS in statistics or equivalent with at least 3 years of clinical trial experience in the pharmaceutical industry.
* Proficient in statistical programming (SAS is required).

What qualifications do we prefer?

* Experience in oncology clinical research is preferred but not required.
* Knowledge of FDA and ICH regulations and guidelines.
* Experience with R is a plus.
* Commitment to Blueprint Medicines' Core Values: Patients First, Thoughtfulness, Urgency, Trust, Optimism.

What capabilities do you bring?

* Experience investigating the relationships between biomarkers and clinical endpoints is desirable but not required.
* Strong interpersonal skills and excellent written/oral communication skills including grammatical/technical writing skills.
* Self-motivation and self-confidence are critical.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Who we are:

We don't think in small steps. We think in giant leaps.

We are driven by the pursuit of new ideas, new innovations, and new ways of thinking.

We know that what each and every one of us matters and that our success depends on our ability to work together in a diverse community. We believe we are at our best as a company when our employees are thriving and foster a culture that provides opportunities to grow and develop professionally, while also having fun.